Official Title: “A 36 Week Randomized, Double-Blind, Parallel Group, Multi-Center, Active-Controlled, Optional Titration Study Comparing an Aliskiren-Based Regimen to a Ramipril-Based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension”

Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: February 2008

Intervention(s) in this Clinical Trial

• Drug: Aliskiren
  • 300 mg
• Drug: Ramipril
  • Ramipril 10 mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Aliskiren 300 mg
• Active Comparator: 2
  • Ramipril 10 mg

Primary Measures

• Change from baseline in Mean Sitting Systolic Blood Pressure
  • Time Frame: 12 and 36 weeks
    Safety Issue?: No

Secondary Measures

• Change from baseline in Mean sitting diastolic blood pressure (msDBP)
  • Time Frame: 12 and 36 weeks
    Safety Issue?: No
• Frequency of Cough
  • Time Frame: 12 and 36 weeks
    Safety Issue?: Yes
• Frequencies of Adverse Events
  • Time Frame: 12 and 36 weeks
    Safety Issue?: Yes
• Change from baseline in the Psychological General Well-Being Index (PGWBI) and the Medical Outcomes Study (MOS) Sleep Scale (Short Form
  • Time Frame: 12 and 36 weeks
    Safety Issue?: No
• Safety and tolerability
  • Time Frame: 12 and 36 weeks
    Safety Issue?: Yes

Inclusion Criteria:

• Male or female outpatients 65 years old or older.
• Patients with mild to moderate systolic hypertension.
• Patients who are eligible and consent to participate in the study

Exclusion Criteria:

• Severe hypertension
• History of CVA, TIA, MI or bypass surgery in the last 6 months
• Severe heart failure, severe chronic kidney disease or severe liver disease.
• Other protocol-defined inclusion/exclusion criteria may apply

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Study Director Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00368277

Study ID Number: CSPP100A2344

ClinicalTrials.gov Identifier: NCT00368277

Health Authority: United States: Food and Drug Administration